Phase 3 Study - Safety and Efficacy of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)

Phase 3

Withdrawn

• Conditions: Skin Structures and Soft Tissue Infections
• Interventions: Drug: PTK 0796; Drug: Linezolid

• Registration Number: NCT00876850
• Lead Sponsor: Paratek Pharmaceuticals Inc

Brief Summary

A Phase III trial to demonstrate the safety and efficacy of PTK 0796 in the treatment of complicated skin and skin structure infections (cSSSI).

Detailed Description

The pharmacologic profile of PTK 0796 in humans suggests that it has the potential to be used safely and effectively for this indication. Data from in vitro and animal studies support this hypothesis.

In PTK 0796-CSSI-0805 the safety and efficacy of PTK 0796 in the treatment of cSSSI will be compared to an antibiotic approved for this indication by the FDA. Initial treatment will be administered intravenously with the option for subsequent oral treatment.

Study Timeline

• Study First Submitted: 2009-04-06
• Study First Submitted QC: 2009-04-06
• Study First Posted: 2009-04-07
• Study Start: 2009-07
• Primary Completion: 2010-07
• Study Completion: 2010-08
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-08
• Last Update Posted: 2012-05-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Has and acute complicated skin and skin structure infection with findings of systemic inflammatory response
• Patients, ages 18 years or older
• Is expected to require greater than or equal to 4 days antibiotic therapy
• Female patients must not be pregnant at the time of enrollment and must agree to a reliable method of birth control during the study and for 30 days following the last dose of study drug

Exclusion Criteria

• Has received an investigational drug within the past 1 month
• Has been previously enrolled in this protocol
• Has received >48hr of potentially effective systemic antibiotic immediately prior to study drug
• Is nursing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PTK 0796	PTK 0796	PTK 0796 100mg for injection; PTK 0796 tablet 150mg
Linezolid	Linezolid	For gram positive treatment: Linezolid 600 mg tablets and pre-mixed 600mg IV infusion solution; For gram negative treatment: Moxifloxacin 400 mg tablets and pre-mixed 400mg IV infusion solution

Primary Outcome Measures

Name	Time	Method
Clinical success at follow-up	4 weeks after enrollment

Secondary Outcome Measures

Name	Time	Method
To evaluate safety of dosing regimens	4 weeks after enrollment